Clinical Trials Assistant (XN03)

Job description

Job responsibilities

The focus of this role is towards meeting the needs of those who participate in clinical trials across the Trust. This role will involve working closely with the senior research nurses, research team, and all members of the multidisciplinary team to, thus facilitating and maintain a high-quality research service. The post holder may be expected to interact with patients and their families in relation to the requirements of the clinical trials and be able to work without supervision in some areas. The post holder will be working within busy clinical trials departments with a portfolio of studies covering a range of conditions. These trials are NIHR funded studies, commercial trails, and academic studies. Clinical trials support is provided to a team of Research Nurses. The post holder is expected to meet all reporting procedure timescales and international, national and local standards for clinical trial governance. The post holder will be required to work alongside academic and industry partners, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Yorkshire and Humber (Y&H) and colleagues in neighbouring establishments, attending regional and national meetings as required. This post supports several clinical research teams around the Trust. The length of time with each team is dependent upon their requirements.

Patient support;

To assist in the evaluation of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving the co-ordination of tests, obtaining results and arranging transport and documentation of specific specimens as per clinical trial protocols

To assist the co-ordination of the patients, journey through the clinical trial protocol e.g., requisition and organisation of any necessary investigations, procurement of patient notes.

Team Working;

To ensure that all members of the multidisciplinary team are aware of the current trials' portfolio; status of studies, and any trial amendments.

The post holder will demonstrate the ability to manage their own administrative caseload, working as part of the multidisciplinary team.

In conjunction with all members of the research team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service.

Administration;

To coordinate the maintenance of all documentation required in site files, including archiving arrangements.

To assist with the collection and collation of trial data and completion of trial documentation in accordance with trial protocols.

To ensure that all data entry is compliant with protocol requirements.

To ensure that all trial data is submitted to the study sponsor within the specified time constraints.

To manage and respond to any data queries received.

To ensure timely entry of recruitment figures to all relevant data bases.

To report monthly to the Senior Research Nurse accrual data on all patients recruited into the study portfolio highlighting local activities that might impact on achievement of the departments aims.

Maintain an agreed level of supplies required across the clinical trials team and complete orders in line with departmental requirements

General;

To contribute to the development of the portfolio of trials. To help implement local and national and international quality standards, professional standards, recommendations and guidelines from national reports.

The post holder will adhere to the Data Protection Act and maintain patient confidentiality at all times. The post holder will always act in a professional manner when dealing with patients, their relatives and representatives from both external and internal sources.

The post holder will deal with telephone enquiries from staff, patients and carers ensuring that appropriate personnel are informed for actions to be taken.

The post holder will be expected to represent the research team in a professional manner at meetings and events. The post holder will be expected to always work to ICH GCP guidelines.

As a new post holder, an induction and training programme will be provided for key aspects of this role, however the post holder will be expected to take advantage of opportunities to attend meetings and workshops to enhance their knowledge of Clinical Research and clinical care.

The staff member will ensure that (s)he follows the Trusts hospital infection prevention and control policies and procedures to protect patients, staff and visitors from healthcare-associated infections. He or she will ensure that(s)he performs the correct hand hygiene procedures, when entering clinical areas.

To undertake any other duties deemed appropriate to the role, including interaction with patients and families when this is deemed appropriate.

Health and Safety/Risk Management

All staff are responsible for working with their colleagues to maintain and improve the quality of services provided to our patients and other service users. This always includes complying with the Leeds Teaching Hospitals NHS Trust Policies, including Health and Safety policies, by following agreed safe working procedures, and reporting incidents using the Trust Incident Reporting system.

Infection Control

The jobholder must always comply with the Leeds Teaching Hospitals NHS Trust Infection Control policies, by practising Universal Infection Control Precautions. Hand hygiene must be performed before and after contact with patients and their environment.

Equality and Diversity

The jobholder must comply with all policies and procedures designed to ensure equality of employment and that services are delivered in ways that meet the individual needs of patients and their families. No person whether they are staff, patient or visitor should receive less favourable treatment because of their gender, ethnic origin, age, disability, sexual orientation, religion etc.

The jobholder must take responsibility in agreement with his/her line manager for his/her own personal development by ensuring that Continuous Professional Development remains a priority. The jobholder will undertake all mandatory training required for the role. Respect for Patient Confidentiality The jobholder should always respect patient confidentiality and not divulge patient information unless sanctioned by the requirements of the role.

Person Specification

Skills & Behaviours

Essential

• Able to always communicate with a range of stakeholders in a pleasant and polite manner.
• Able to communicate in an environment of continuous change.
• Ability to work independently and manage own day-to-day workload, prioritising as needed with a flexible and positive approach.

Experience

Essential

• Administrative experience
• Able to work unsupervised
• Familiar with the process of clinical trials
• Understanding of the principals of clinical research

Desirable

• Knowledge of research methodologies
• Clinical Trials experience
• Experience of contact with patients in either a clinical or research setting.
• Experience of working in the NHS.

practical skills or Additional Requirements

Essential

• Excellent standard of written and spoken English.
• Comprehensive knowledge of Microsoft software packages.
• Excellent computer literacy skills.

Qualifications

Essential

• Good standard of education to a minimum of GCSE level
• A willingness to undergo personal development and learn new skills.

Desirable

• GCP training

Qualifications

Essential

• Good standard of education to a minimum of GCSE level
• A willingness to undergo personal development and learn new skills.

Desirable

• GCP training

Qualifications

Essential

• Good standard of education to a minimum of GCSE level
• A willingness to undergo personal development and learn new skills.

Desirable

• GCP training

Experience

Essential

• Administrative experience
• Able to work unsupervised
• Familiar with the process of clinical trials
• Understanding of the principals of clinical research

Desirable

• Knowledge of research methodologies
• Clinical Trials experience
• Experience of contact with patients in either a clinical or research setting.
• Experience of working in the NHS.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Leeds Teaching Hospitals

Address

St. James's University Hospital

Beckett Street

Leeds

LS9 7TF

Employer's website

https://www.leedsth.nhs.uk/ (Opens in a new tab)